MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-40

Device Problems Difficult to Advance (2920); Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993); Protective Measures Problem (3015)

Patient Problems Erythema (1840); Paralysis (1997); Swelling (2091); Weakness (2145); Ambulation Difficulties (2544); No Known Impact Or Consequence To Patient (2692)

Event Date 03/06/2019

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: 8598a, serial/lot #: (b)(4), ubd: 05-jul-2020, udi#: (b)(4), implanted: (b)(6) 2019, product id: 8596sc, serial/lot #: (b)(4), ubd: 26-apr-2019, udi#: (b)(4), implanted: (b)(6) 2019.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) via a manufacturer's representative (rep) regarding a patient who was receiving 1000 mcg/ml of fentanyl at 200 mcg/day and 10 mg/ml of bupivacaine at 2 mg/day via an implantable pump for spinal pain.On (b)(6) 2019, it was reported that during a catheter replacement on (b)(6) 2019, the hcp had difficulty advancing the new catheter and could not aspirate from the catheter.The rep reported that this was a "weird" case and they had trouble "threading" the catheter into the intrathecal space.The hcp determined it was not in the epidural space and pushed contrast through confirming that dye was able to propel through the catheter.However, the hcp could not "retract" the contrast.It was reported that they were never able to aspirate successfully during the case and never got csf back.The hcp believed that it was because there was too much hardware in the spine.The patient reported to the rep that after the replacement they could not move their right foot but could still feel it.No further complications were reported.

Manufacturer Narrative

Product id: 8598a, serial# (b)(4), implanted: (b)(6) 2019, explanted: (b)(6) 2019, product type: catheter; product id: 8596sc, serial# (b)(4), implanted: (b)(6) 2019, explanted: (b)(6) 2019, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacturer representative on 2019-mar-13.It was reported that the catheter was removed on (b)(6) 2019 and it was unknown how the patient was doing post-removal.

Manufacturer Narrative

Updated to reflect the information received on 2019-mar-14.Corrected to reflect the report of the serious injury received on 2019-mar-13.Device code (b)(4) was added to reflect the information received on 2019-mar-14.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare provider via a manufacturer's representative on 2019-mar-14.It was reported that the cause of the patient's inability to move their right foot was unknown.The hcp noted that they were unable to tell where the catheter was in the spine on the ct and mri.However, the difficulty threading the catheter and being unable to aspirate the catheter was considered resolved.No further complications were reported.

Manufacturer Narrative

Patient weight updated to reflect the information received on 2019-apr-23.Outcomes attributed to adverse event updated to include hospitalization per information received on 2019-apr-23.Event description updated to include information received on 2019-apr-23.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare provider via a clinical study on 2019-apr-23.It was reported that the hcp received a voicemail from the patient on (b)(6) 2019 who reported that their "right leg has been paralyzed" since surgery.The patient later clarified that they were unable to wiggle their toes or bear weight on the right leg.It was noted that the patient was experiencing leg weakness and a loss of mobility.The patient was sent for a lumbothoracic mri without contrast on (b)(6) 2019.No changes related to procedure or implanted device were noted following the mri on (b)(6) 2019.The physician's assistant caring for the patient called to inform of redness and swelling around the surgery sites following the catheter explant on (b)(6) 2019.The patient was to be sent to the pain clinic for aspiration after they were discharged.On (b)(6) 2019, the hospital informed the hcp that the patient was being treated in the rehab center.The patient was not discharged to the pain clinic.It was reported that this event required in-patient or prolonged hospitalization as well as an emergency room visit.The event was ongoing.The etiology indicated the event was possibly related to the device or therapy and was possibly related to the implant procedure.No further complications were reported.

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the manufacturer's representative.The cause of the redness and swelling around the surgical site and the leg weakness was unknown.It was also unknown if the patient's symptoms had resolved.It was reported the explanted catheters had been disposed of at the account and would not be returned for analysis.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 8413813
• MDR Text Key: 139239393
• Report Number: 3004209178-2019-05080
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630512
• UDI-Public: 00643169630512
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2020
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 63